MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION; NADH OXIDATION/NAD REDUCTION, ALT/SGPT

Catalog Number	05850797190
Medical Device Problem Codes	False Negative Result (1225); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).The 2 other methods were ortho and hitachi.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned low results for 3 samples from 1 patient tested for alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation (alt) on a cobas 8000 c 702 module.The patient had a liver transplant in (b)(6) 2024.Following the transplant, the patient was tested for alt "multiple times" by 2 other methods and the results were all "normal" but the ast results were elevated.The c702 module was installed at the customer site in (b)(6) 2024.The customer ran the samples that were drawn in (b)(6) 2024 on the c702 module and the results were consistent with the alt results from the other methods.The customer suspects an interference as the patient¿s ast results were high but the alt results were "normal." note: the unit of measure was not provided.Sample 1: the initial result was 34.9.The result from a 1:10 dilution was 27.5.The altlp result was 44.4.Sample 2: the initial result was 35.9.The result from a 1:10 dilution was 30.8.The altlp result was 47.1.Sample 3: the initial result was 36.4.The result from a 1:10 dilution was 29.4.The altlp result was 44.2.
Additional Manufacturer Narrative
The customer did not provide any additional information for the investigation.The ast results were considered to be elevated which may be related to the heart disease mentioned (the patient has elevated clinical heart marker results).The "normal" alt results are most likely correct.No data was provided that would indicate the alt results were "false normal" or too low.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION
• Common Device Name: NADH OXIDATION/NAD REDUCTION, ALT/SGPT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20205614
• Report Number: 1823260-2024-02645
• Device Sequence Number: 6750007
• Product Code: CKA
• UDI-Device Identifier: 04015630928927
• UDI-Public: 04015630928927
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 05850797190
• Device Lot Number: 743176
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown